Trial Outcomes & Findings for An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment (NCT NCT01770652)
NCT ID: NCT01770652
Last Updated: 2014-08-26
Results Overview
Cmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal, mild, moderate and severe renal impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
24-hour interval
Results posted on
2014-08-26
Participant Flow
Participant milestones
| Measure |
Normal Hepatic Function (Healthy Volunteers)
Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Mild Renal Impairment
Mild renal impairment defined as eGFR 60-89 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Moderate Renal Impairment
Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Severe Renal Impairment
Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment
Baseline characteristics by cohort
| Measure |
Normal Hepatic Function (Healthy Volunteers)
n=8 Participants
Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Mild Renal Impairment
n=8 Participants
Mild renal impairment defined as eGFR 60-89 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Moderate Renal Impairment
n=8 Participants
Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Severe Renal Impairment
n=8 Participants
Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
32 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24-hour intervalPopulation: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
Cmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal, mild, moderate and severe renal impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.
Outcome measures
| Measure |
Normal Renal Function (Healthy Volunteers)
n=8 Participants
Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Mild Renal Impairment
n=8 Participants
Mild renal impairment defined as eGFR 60-89 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Moderate Renal Impairment
n=8 Participants
Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Severe Renal Impairment
n=8 Participants
Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
|---|---|---|---|---|
|
Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Cmax for serum deferiprone
|
37.1 μg/mL
Standard Deviation 12.0
|
33.4 μg/mL
Standard Deviation 9.5
|
43.3 μg/mL
Standard Deviation 22.9
|
30.6 μg/mL
Standard Deviation 16.2
|
|
Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Cmax for serum deferiprone-3-o-glucuronide
|
47.8 μg/mL
Standard Deviation 6.2
|
60.8 μg/mL
Standard Deviation 10.3
|
118.8 μg/mL
Standard Deviation 48.3
|
150.8 μg/mL
Standard Deviation 32.4
|
PRIMARY outcome
Timeframe: 24 hour intervalPopulation: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
Tmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose. The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation).
Outcome measures
| Measure |
Normal Renal Function (Healthy Volunteers)
n=8 Participants
Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Mild Renal Impairment
n=8 Participants
Mild renal impairment defined as eGFR 60-89 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Moderate Renal Impairment
n=8 Participants
Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Severe Renal Impairment
n=8 Participants
Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
|---|---|---|---|---|
|
Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Tmax for Serum Deferiprone
|
0.50 hour
Interval 0.25 to 1.0
|
0.75 hour
Interval 0.5 to 1.0
|
1.00 hour
Interval 0.5 to 2.0
|
0.75 hour
Interval 0.25 to 4.0
|
|
Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Tmax for Serum Deferiprone 3-O-glucuronide
|
2.50 hour
Interval 1.33 to 3.0
|
2.50 hour
Interval 2.0 to 3.0
|
3.00 hour
Interval 2.0 to 6.0
|
4.00 hour
Interval 2.0 to 6.0
|
PRIMARY outcome
Timeframe: 24 hour intervalPopulation: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
AUC0-∞ was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.
Outcome measures
| Measure |
Normal Renal Function (Healthy Volunteers)
n=8 Participants
Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Mild Renal Impairment
n=8 Participants
Mild renal impairment defined as eGFR 60-89 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Moderate Renal Impairment
n=8 Participants
Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Severe Renal Impairment
n=8 Participants
Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
|---|---|---|---|---|
|
AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide
AUC0-∞ for serum deferiprone 3-O-Glucuronide
|
78.1 μg*h/mL
Standard Deviation 27.8
|
76.9 μg*h/mL
Standard Deviation 15.7
|
74.9 μg*h/mL
Standard Deviation 15.1
|
70.9 μg*h/mL
Standard Deviation 8.5
|
|
AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide
AUC0-∞ for serum deferiprone
|
252.6 μg*h/mL
Standard Deviation 35.4
|
319.1 μg*h/mL
Standard Deviation 54.1
|
703.2 μg*h/mL
Standard Deviation 229.6
|
1438.5 μg*h/mL
Standard Deviation 335.5
|
PRIMARY outcome
Timeframe: 24 hour intervalPopulation: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.
Outcome measures
| Measure |
Normal Renal Function (Healthy Volunteers)
n=8 Participants
Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Mild Renal Impairment
n=8 Participants
Mild renal impairment defined as eGFR 60-89 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Moderate Renal Impairment
n=8 Participants
Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Severe Renal Impairment
n=8 Participants
Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
|---|---|---|---|---|
|
T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide
T1/2 for Serum Deferiprone
|
1.68 hour
Standard Deviation 0.27
|
1.77 hour
Standard Deviation 0.17
|
2.03 hour
Standard Deviation 0.32
|
2.20 hour
Standard Deviation 0.91
|
|
T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide
T1/2 for Serum Deferiprone 3-O-Glucuronide
|
2.14 hour
Standard Deviation 0.32
|
2.58 hour
Standard Deviation 0.45
|
2.58 hour
Standard Deviation 0.38
|
3.35 hour
Standard Deviation 0.48
|
PRIMARY outcome
Timeframe: 24 hour intervalPopulation: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
Ae24 (the amount excreted in urine from time zero to 24 hours) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Urine samples were collected at the intervals of -2 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post-dose.
Outcome measures
| Measure |
Normal Renal Function (Healthy Volunteers)
n=8 Participants
Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Mild Renal Impairment
n=8 Participants
Mild renal impairment defined as eGFR 60-89 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Moderate Renal Impairment
n=8 Participants
Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Severe Renal Impairment
n=8 Participants
Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
|---|---|---|---|---|
|
Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide
Ae24 for urine deferiprone
|
78 mg
Standard Deviation 33
|
69 mg
Standard Deviation 20
|
36 mg
Standard Deviation 12
|
24 mg
Standard Deviation 10
|
|
Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide
e24 for urine deferiprone 3-O-Glucuronide
|
5987 mg
Standard Deviation 1332
|
6608 mg
Standard Deviation 1630
|
5812 mg
Standard Deviation 929
|
5318 mg
Standard Deviation 1683
|
PRIMARY outcome
Timeframe: 24-hour intervalPopulation: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter
Fe24 (fraction of dose excreted in urine from time zero to 24 hours) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Urine samples were collected at the intervals of -2 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post-dose. Some of the Fe24 values were over 100% which could be explained by variability in urine collection (e.g. incomplete collection of urine into the container) and volume measurement, as well as analytical imprecision.
Outcome measures
| Measure |
Normal Renal Function (Healthy Volunteers)
n=8 Participants
Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Mild Renal Impairment
n=8 Participants
Mild renal impairment defined as eGFR 60-89 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Moderate Renal Impairment
n=8 Participants
Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Severe Renal Impairment
n=8 Participants
Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
|---|---|---|---|---|
|
Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide
Fe24 for urine deferiprone
|
3.5 % of dose excreted in urine from 0-24 hr
Standard Deviation 1.6
|
2.9 % of dose excreted in urine from 0-24 hr
Standard Deviation 0.6
|
1.5 % of dose excreted in urine from 0-24 hr
Standard Deviation 0.5
|
1.0 % of dose excreted in urine from 0-24 hr
Standard Deviation 0.4
|
|
Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide
Fe24 for urine deferiprone 3-O-glucuronide
|
115.0 % of dose excreted in urine from 0-24 hr
Standard Deviation 16.2
|
123.2 % of dose excreted in urine from 0-24 hr
Standard Deviation 12.7
|
104.5 % of dose excreted in urine from 0-24 hr
Standard Deviation 11.6
|
97.9 % of dose excreted in urine from 0-24 hr
Standard Deviation 28.5
|
SECONDARY outcome
Timeframe: From time of dosing until 72 hours post-doseThe number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of Ferriprox.
Outcome measures
| Measure |
Normal Renal Function (Healthy Volunteers)
n=8 Participants
Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Mild Renal Impairment
n=8 Participants
Mild renal impairment defined as eGFR 60-89 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Moderate Renal Impairment
n=8 Participants
Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Severe Renal Impairment
n=8 Participants
Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
|---|---|---|---|---|
|
Safety and Tolerability of Ferriprox® in Subjects With Renal Impairment.
|
2 participants
|
5 participants
|
1 participants
|
1 participants
|
Adverse Events
Normal Hepatic Function (Healthy Volunteers)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Mild Renal Impairment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Moderate Renal Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Severe Renal Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normal Hepatic Function (Healthy Volunteers)
n=8 participants at risk
Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Mild Renal Impairment
n=8 participants at risk
Mild renal impairment defined as eGFR 60-89 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Moderate Renal Impairment
n=8 participants at risk
Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
Severe Renal Impairment
n=8 participants at risk
Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m\^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.
Deferiprone
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
12.5%
1/8 • Number of events 1 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
12.5%
1/8 • Number of events 1 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
12.5%
1/8 • Number of events 1 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
12.5%
1/8 • Number of events 1 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
12.5%
1/8 • Number of events 1 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
|
Nervous system disorders
Somnolence
|
12.5%
1/8 • Number of events 1 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
37.5%
3/8 • Number of events 3 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
12.5%
1/8 • Number of events 1 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
|
Renal and urinary disorders
Dysuria
|
12.5%
1/8 • Number of events 2 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.5%
1/8 • Number of events 1 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8 • Number of events 1 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
|
Nervous system disorders
Chills
|
12.5%
1/8 • Number of events 1 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
0.00%
0/8 • Up to 4 days: from the time of administration of study drug until a follow-up telephone call 48 to 72 hours after discharge
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60